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A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects

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NCT02813798

Last updated on April 21, 2018
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FOR MORE INFORMATION
Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Impairment, Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Female subjects of non-childbearing potential or male subjects

- Body Mass Index (BMI) of 17.5 to 40.0 kg/m2

- Stable renal function

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- A positive urine drug screen for illicit drugs

- Treatment with an investigational drug within 30 days of the dose of study medication

- Pregnant females, breastfeeding female subjects and male subjects with partners
currently pregnant

- Use of herbal supplements in the 28 days prior to the dose of study medication

- Blood donation (excluding plasma donation) of approximately 1 pint or more within 56
days prior to study medication

- Requiring dialysis

NCT02813798
Pfizer
Completed
A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects

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A Study to Evaluate the Effect of IV Doses of Rivipansel on Subjects With Renal Impairment and in Healthy Subjects
A Phase 1, Non-randomized, Open-label, Single Dose Study To Evaluate The Effect Of Renal Impairment On The Pharmacokinetics, Safety And Tolerability Of Rivipansel (Pf-06460031) In Subjects With Renal Impairment And In Healthy Subjects
The purpose of this study is to determine the effect of renal impairment on rivipansel.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
  • Renal Impairment
  • Healthy
Drug: Rivipansel
A single 840mg dose of Rivipansel over 20 minutes
Other Name: GMI-1070
  • Experimental: Mild Renal Impairment
    A single dose of IV Rivipansel over 20 minutes
    Intervention: Drug: Rivipansel
  • Experimental: Moderate Renal Impairment
    A single dose of IV Rivipansel over 20 minutes
    Intervention: Drug: Rivipansel
  • Experimental: Severe Renal Impairment
    A single dose of IV Rivipansel over 20 minutes
    Intervention: Drug: Rivipansel
  • Experimental: Normal Renal Functions
    A single dose of IV Rivipansel over 20 minutes
    Intervention: Drug: Rivipansel
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
28
January 2018
January 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female subjects of non-childbearing potential or male subjects
  • Body Mass Index (BMI) of 17.5 to 40.0 kg/m2
  • Stable renal function

Exclusion Criteria:

  • A positive urine drug screen for illicit drugs
  • Treatment with an investigational drug within 30 days of the dose of study medication
  • Pregnant females, breastfeeding female subjects and male subjects with partners currently pregnant
  • Use of herbal supplements in the 28 days prior to the dose of study medication
  • Blood donation (excluding plasma donation) of approximately 1 pint or more within 56 days prior to study medication
  • Requiring dialysis
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT02813798
B5201005
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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